BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998

    K Number: K091355 · Decision Jul 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
    K Number
    K091355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conmed Endoscopic Technologies, Inc.
    Date Received
    May 8, 2009
    Decision Date
    July 22, 2009
    Product Code
    FDI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FDI Snare, Flexible

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    Other Clearances by Conmed Endoscopic Technologies, Inc.

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